MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TGMR313115J

Device Problems Inadequacy of Device Shape and/or Size (1583); Migration (4003)

Patient Problems Complaint, Ill-Defined (2331); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

According to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, component migration and endoleak.

Event Description

The following was reported to gore: on (b)(6) 2020, the patient underwent endovascular treatment of a thoracic aortic acute type b dissection and ulcer-like projection (ulp) using a gore® tag® conformable thoracic stent graft with active control system.The gore® tag® conformable thoracic stent graft with active control system was implanted from just below to the left subclavian artery.The procedure was completed without any endoleak.On an unknown date in (b)(6) 2020 (about 2 weeks later since the initial procedure), the ct imaging revealed that a proximal type i endoleak and a migration (approximately 5mm).The reintervention is planned.The physician suggested that the migration might have occurred because the stent graft was not following the grater greater curvature.Additional information from the company representative stated that it is possible that the proximal end of the ctag ac was slightly undersized for the diameter of the aorta.

Manufacturer Narrative

H6: code 4581 is used to capture proximal type i endoleak.H6: code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.H6: added codes 4625 and 4629 for health effect impact.

• Brand Name: GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10697839
• MDR Text Key: 212482032
• Report Number: 2017233-2020-01364
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2022
• Device Catalogue Number: TGMR313115J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 03/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR